Validation of the GenoType®MTBDRplus assay for diagnosis of multidrug resistant tuberculosis in South Vietnam

BMC Infectious Diseases

Research Article

Frank GJ Cobelens¹  Richard O'Brien²  Edine W Tiemersma³  Dinh N Sy⁴  Nguyen TN Lan⁵  Pham T Hang⁵  Mai NT Huyen⁵  Tran N Buu⁵  Nguyen H Dung⁵  Kristin Kremer⁶  Dick van Soolingen⁷  Maxine Caws⁸ 

[1] Center for Poverty-related Communicable Diseases, Amsterdam Institute of Global Health and development, Academic Medical Center, Meibergdreef 9, 1105, Amsterdam, AZ, The Netherlands;Foundation for Innovative New Diagnostics (FIND), Avenue de Budé 16, 1202, Geneva, Switzerland;KNCV Tuberculosis Foundation, PO Box 146, 2501, The Hague, CC, The Netherlands;Center for Poverty-related Communicable Diseases, Amsterdam Institute of Global Health and development, Academic Medical Center, Meibergdreef 9, 1105, Amsterdam, AZ, The Netherlands;National Lung Hospital, 463 Hoang Hoa Tham, Ba Dinh district, Ha Noi, Viet Nam;Phạm Ngọc Thạch hospital, 120 Hung Vuong, district 5, Ho Chi Minh City, Viet Nam;Tuberculosis Reference Laboratory, RIVM, PO Box 1, 3720, Bilthoven, BA, The Netherlands;Tuberculosis Reference Laboratory, RIVM, PO Box 1, 3720, Bilthoven, BA, The Netherlands;Departments of Pulmonary Diseases and Medical Microbiology, Radboud University, PO box 91016500, Nijmegen, HB, The Netherlands;Wellcome Trust Major Overseas Programme, Oxford University Clinical Research Unit, Hospital for Tropical Diseases, 190 Ben Ham Tu, District 5, Ho Chi Minh City, Viet Nam;

关键词: Drug Susceptibility Testing;    rpoB Gene;    katG Gene;    Beijing Genotype;    Drug Susceptibility Testing Result;   

DOI  :  10.1186/1471-2334-10-149

 received in 2009-12-18, accepted in 2010-06-03,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundTo control multidrug resistant tuberculosis (MDR-TB), the drug susceptibility profile is needed to guide therapy. Classical drug susceptibility testing (DST) may take up to 2 to 4 months. The GenoType® MTBDRplus test is a commercially available line-probe assay that rapidly detects Mycobacterium tuberculosis (MTB) complex, as well as the most common mutations associated with rifampin and isoniazid resistance.We assessed sensitivity and specificity of the assay by using a geographically representative set of MTB isolates from the South of Vietnam.MethodsWe re-cultured 111 MTB isolates that were MDR, rifampin-resistant or pan-susceptible according to conventional DST and tested these with the GenoType® MTBDRplus test.ResultsBy conventional DST, 55 strains were classified as MDR-TB, four strains were rifampicin mono-resistant and 52 strains were susceptible to all first-line drugs. The sensitivity of the GenoType® MTBDRplus was 93.1% for rifampicin, 92.6% for isoniazid and 88.9% for the combination of both; its specificity was 100%. The positive predictive value of the GenoType® MTBDRplus test for MDR-TB was 100% and the negative predictive value 90.3%.ConclusionsWe found a high specificity and positive predictive value of the GenoType® MTBDRplus test for MDR-TB which merits its use in the MDR-TB treatment program in Vietnam.

【 授权许可】

Unknown   
© Huyen et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.